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FDA 510(k)

PROOF POSITIVE ELECTRONIC PREGNANCY TEST

K-Number: K043231 · 2005-04-25

ApplicantMizuho USA, Inc.
Decision Date2005-04-25
Product CodeLCX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROOF POSITIVE ELECTRONIC PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Mizuho USA, Inc.. It received FDA 510(k) clearance on 2005-04-25 under 510(k) number K043231. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROOF POSITIVE ELECTRONIC PREGNANCY TEST?

PROOF POSITIVE ELECTRONIC PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 2005-04-25. The listed applicant is Mizuho USA, Inc.. The 510(k) number is K043231.

When did PROOF POSITIVE ELECTRONIC PREGNANCY TEST receive FDA 510(k) clearance?

PROOF POSITIVE ELECTRONIC PREGNANCY TEST received FDA 510(k) clearance on 2005-04-25, under 510(k) number K043231.

Who is the listed applicant for PROOF POSITIVE ELECTRONIC PREGNANCY TEST?

The FDA 510(k) record lists Mizuho USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROOF POSITIVE ELECTRONIC PREGNANCY TEST?

The FDA product code for PROOF POSITIVE ELECTRONIC PREGNANCY TEST is LCX.

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Other records listing Mizuho USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K060825MULTI-USE ELECTRONIC PREGNANCY TESTK000844ABSOLUTE HCG PREGNANCY TESTK964002NATURALE HCG PREGNANCY TESK943859QUICK CHECKER HCG PREGNANCY TESTK945568HCG MIDSTREAM PREGNANCY TESTK931997HCG MIDSTREAM PREGNANCY TEST

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Related Devices (Code: LCX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251040MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy TestGuangzhou Decheng Biotechnology Co., Ltd.K251053Shinetell PlusTM Digital Early Pregnancy TestHangzhou AllTest Biotech Co., Ltd.K250117FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteAssure Tech., LLCK242135Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test MidstreamNanjing Synthgene Medical Technology Co., Ltd.K243573FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test MidstreamAssure Tech., LLCK241394iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripAndon Health Co, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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